510(k) K201634

RG 3ml Medication Cartridge by Chengdu Shifeng Medical Technology Co., Ltd. — Product Code MRZ

K201634 is an FDA 510(k) premarket notification submitted by Chengdu Shifeng Medical Technology Co., Ltd. for the device "RG 3ml Medication Cartridge". The FDA issued a decision of Substantially Equivalent on March 26, 2021. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
June 16, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type